LUPUZOR™ UPDATE. PK study commencement approved by MHRA – patient dosing to commence imminently7th February 2022 - 10:55 am
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is delighted to provide an update on the Lupuzor™ pharmacokinetic (“PK”) study, as part of the new optimised international Phase 3 trial of Lupuzor™ in Lupus patients.
- Medical and Health Products Regulatory Agency (“MHRA”) approves commencement of the PK study
- Volunteers have been selected and approved for inclusion in the PK study
- Volunteer dosing to commence on 15 February 2022
- Study on track to deliver results around the end Q1 2022
Following the approval from the US Food & Drug Administration (“FDA”) of the protocol for the pharmacokinetic (“PK”) study and local Ethics committee approval, ImmuPharma has been working with Avion Pharmaceuticals (“Avion”), our exclusive US partner, and our Contract Research Organisation (“CRO”), Simbec-Orion, together with additional specialist service providers, to prepare the commencement of the study.
As part of the regulatory process, the Investigational Medicinal Product Dossier (“IMPD”) required significant revision, due to the inclusion of a new proprietary synthesis of P140, which consequently affords greater IP protection and lower cost of goods. The new IMPD was submitted to the MHRA and, following a full review, the MHRA has approved the commencement of the PK study.
The PK study is a Phase I study to assess the presence of Lupuzor™ in the body after administration of a single dose. The study will be carried out in a total of up to 24 healthy male volunteers.
Volunteers have been selected and approved with dosing to commence on 15 February 2022. As previously advised, we expect study results to be available around the end of Q1 2022.
Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said:
“We are extremely pleased to see this next positive step for Lupuzor™, with approval from the MHRA to commence the PK study. We look forward to moving Lupuzor™ forward into the optimised Phase 3 study, in collaboration with our partner Avion, on the successful completion of the PK study. The study is on track to deliver results around the end of Q1 2022.”
Dr Tim Franklin, Chief Operating Officer, added:
“The ImmuPharma Biotech team in Bordeaux and I are looking forward to the near-term completion of the PK study. Our CRO, Simbec-Orion, and other key collaborators including Prof. Sylviane Muller, have provided invaluable contribution in completing a robust and improved IMPD to the MHRA. We look forward with Avion to moving Lupuzor™ forward and in parallel, we will continue to focus on unlocking further value through the other indications within the P140 platform and the anti-infective programs.”
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